Radiotherapy for Head and Neck Cancer on One Side of the Neck
Randomized Trial of Unilateral vs. Bilateral Neck Irradiation in Head and Neck Cancer Patients Treated With Primary Surgery
This study is testing if giving radiation treatment only to the side of the neck with cancer can be just as safe and effective for patients with head and neck cancer, while also reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT03622164 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering radiotherapy only to the side of the neck affected by cancer in patients with head and neck neoplasms. Traditionally, patients receive radiation on both sides of the neck, which can lead to significant side effects and impact quality of life. By randomizing participants to receive either unilateral or bilateral radiotherapy, the study aims to determine if limiting treatment to one side is safe and effective. The goal is to potentially change the standard of care to reduce unnecessary side effects for patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with squamous cell carcinoma of the head and neck who have undergone surgery and have no disease on the contralateral side.
Not a fit: Patients with previous radiation to the head and neck area or those with contraindications to radiation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce side effects and improve the quality of life for patients with head and neck cancer.
How similar studies have performed: There is growing evidence from other studies suggesting the safety of omitting radiotherapy on the side of the neck without disease, indicating this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with squamous cell carcinoma of the head and neck undergoing primary surgical management are eligible to participate if they meet the following eligibility criteria: * Age ≥18 * Primary site of disease in the oral cavity, oropharynx, larynx, or hypopharynx. * Squamous cell carcinoma confirmed by histology. * Bilateral modified radical or selective neck dissections carried out as part of primary surgery, with \>= 10 lymph nodes removed from the contralateral neck * The contralateral neck is pathologically negative * Pre-surgical FDG-PET/CT scan did not show any clinically involved contralateral neck nodes. * Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. Exclusion Criteria: * Previous radiation to the head and neck area * Pregnancy * Other contraindications to radiation treatment (e.g. severe connective tissue disease).
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.